Infertility, Ovulation Induction
Conditions
Keywords
Infertility, Ovulation induction, Luveris, Controlled ovarian stimulation, Reproductive technologies, assisted
Brief summary
This is a multicentric, open, randomized, comparative trial aimed to assess the influence of recombinant luteinizing hormone (r-LH) supplementation during controlled ovarian stimulation (COS) in advanced reproductive age in terms of improved embryo competence which allows to transfer less embryos to avoid high grade multiple pregnancy without reducing the pregnancy rate.
Detailed description
This study will be carried out by the Grupo de Interés de Salud Embrionaria (GISE) group (part of the Spanish Fertility Society) who uses strict criteria to select the embryos most suitable for successful transference. OBJECTIVES Primary objective: * To determine the benefit of r-LH supplementation in COS prior to in-vitro fertilization (IVF)/intracytosolic sperm injection (ICSI) in advanced reproductive age, in terms of embryo competence to implant, as compared against no r-LH supplementation Secondary objectives: To evaluate the benefit of r-LH supplementation in COS, in terms of: * follicular development * length of the stimulation * oocyte number and their maturity * fertilization rate * embryo number and quality * gestational sacs * abortion * ongoing pregnancies * local and systemic safety of r-LH administration The study will consist of 2 groups randomized in 1:1 ratio and each subject would be followed up until the confirmation of her pregnancy status. Each subject will be administered gonadotropin releasing hormone (GnRH) agonist subcutaneously daily from previous mid luteal phase to r-hCG administration as a standard practice to achieve down regulation. Each subject will also be administered recombinant follicle stimulating hormone (r-FSH) at a starting dose of 300 IU from S1 up to ovarian stimulation completion (r-hCG day) as a part of standard practice. In addition to the above concurrent therapies, one group will be administered experimental treatment (Luveris®) and the other group (control group) will not be administered any other drug (control treatment) during the stimulation period from stimulation start (S1) up to ovarian stimulation completion or stimulation cancellation respectively. Ovarian stimulation on an average takes 11 days and it is expected that stimulation period will not be extended beyond 15 days. A single injection of r-hCG will be administered intramuscularly or subcutaneously after the last injection of Luveris or r-FSH to achieve final follicular maturation. After, 34-36 hours of administration of r-hCG OPU will be done for oocyte retrieval and embryo transfer (ET) will be conducted within 5 days from OPU. Subjects will also be provided luteal support with natural progesterone and will be followed until delivery or miscarriage. Ultrasound and estradiol (E2) assessment of follicular growth will be conducted at various time points during the stimulation period with or without treatment adjustment.
Interventions
DRUGRecombinant human luteinizing hormone (rhLH)
Sponsors
Merck, S.L., Spain
Merck KGaA, Darmstadt, Germany
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
35 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Pre-menopausal female subject aged greater than (\>) 35 years * Subjects with baseline FSH serum level less than or equal to (\<=) 10 IU/liter (l), LH and E2 levels within local normal range and plasma prolactin levels \< 30 nanogram/milliliter (ng/ml) * Subjects with regular spontaneous menstrual cycles of 25-35 days * Subjects with infertility justifying IVF/ICSI-ET treatment * Subjects programmed for COS with r-FSH under GnRH agonist protocol * Sperm from current male partner suitable for IVF/ICSI according to local lab, unless sperm donor is foreseen * Subjects with presence of both ovaries * Subjects whose uterine cavity is able to sustain embryo implantation or pregnancy * Subjects with normal papanicolaou test (PAP) smear within previous 3 years * Subjects with body mass index (BMI) \< 30 at stimulation start * Subjects who receive confirmation of not being pregnant by a negative beta-hCG test (urine or blood) prior to starting r-FSH administration * Subjects willing and able to comply with the protocol for the duration of the study * Subjects who have given informed consent prior to any study-related procedure not part of normal medical care
Exclusion criteria
* Subjects or her male partners who are known to be human immunodeficiency virus, hepatitis B virus or hepatitis C virus positive * Subjects with any clinically significant systemic disease; tumors of the hypothalamus and pituitary gland; ovarian, uterine or mammary cancer; hormonal abnormality and/or medical, biochemical, hematological condition which in the judgment of the investigator may interfere with gonadotropin treatment * Subjects with more than 2 previous assisted reproductive technologies (ART) cycles * Subjects in which previous cycles were cancelled due to poor response (\< 3 antral follicles after 15 day of stimulation) * Subjects with cryopreserved embryos from previous ART cycles * Subjects with unexplained gynecological bleeding * Subjects with polycystic ovaries, ovarian enlargement or cyst of unknown etiology * Subjects known to have any contraindication to being pregnant and/or carrying pregnancy to term * Subjects with known allergy to gonadotrophin preparations or any of the excipients * Subjects known to have any active substance abuse or history of drug, medication or alcohol abuse in the past 5 years * Subjects with previous entry into this study or simultaneous participation in another clinical drug trial * Subjects who have refused to or inability to comply with the protocol
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Implantation Rate | Day 35-42 post ovum pick-up (OPU) (34-38 hours post recombinant human choriogonadotropin day {end of stimulation cycle}[approximately 28 days]) | Implantation rate was measured as the number of gestational sacs observed, divided by the number of embryos transferred. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Number of Oocytes Retrieved | 34-38 hours post r-hCG day (end of stimulation cycle [approximately 28 days]) | Mean number of oocytes retrieved per reporting group on the day of OPU (34-38 hours post r-hCG day (end of stimulation cycle \[approximately 28 days\]) was calculated. Oocyte retrieval is a technique used in in-vitro fertilization in order to remove oocytes from the ovary of the female, enabling fertilization outside the body. |
| Number of Mature Oocytes Retrieved | 34-38 hours post r-hCG day (end of stimulation cycle [approximately 28 days]) | Number of mature oocytes retrieved per reporting group on the day of OPU (34-38 hours post r-hCG day (end of stimulation cycle \[approximately 28 days\]) was calculated. Oocyte retrieval is a technique used in in-vitro fertilization in order to remove oocytes from the ovary of the female, enabling fertilization outside the body. The nuclear maturity was evaluated based on the presence of a germinal vesicle (GV) or whether oocytes were in metaphase I (Meta-I) or II (Meta-II) stage. |
| Number of Fertilized Oocytes (2 Pronuclei [PN]) | 34-38 hours post r-hCG day (end of stimulation cycle [approximately 28 days]) | Oocytes were fertilized using Intra-cytoplasmic Sperm Injection (ICSI) technique which is an in-vitro fertilization procedure in which a single sperm is injected directly into an egg under a microscope. The appearance of two 2PN is the first sign of successful fertilization as observed during in vitro fertilization, and is usually observed after ICSI. The zygote is then termed 2PN. |
| Number and Quality of Embryos | Day 2-3 post OPU (34-38 hours post r-hCG day {end of stimulation cycle}[approximately 28 days]) | Embryos were graded according to Spanish Association for the Study of Reproductive Biology (ASEBIR) criteria into different categories: (A) optimal quality with maximum capacity for implantation, (B) good quality with a high capacity for implantation, (C) regular with low possibility of implantation and (D) poor quality with very little possibility of implantation. |
| Number of Participants With Biochemical Pregnancies | 2 months after OPU (34-38 hours post r-hCG day {end of stimulation cycle} [approximately 28 days]) | Biochemical pregnancy was defined as a pregnancy diagnosed only by the detection of hCG in serum or urine and that does not develop into a clinical pregnancy. |
| Number of Participants With Clinical Pregnancies | 2 months after OPU (34-38 hours post r-hCG day {end of stimulation cycle} [approximately 28 days]) | Clinical pregnancy was defined as pregnancy diagnosed by ultrasonographic visualization of one or more gestational sacs or definitive clinical signs of pregnancy. It includes ectopic pregnancy. |
| Total Dose of Recombinant Follicle Stimulating Hormone (r-FSH) | 2 months after OPU (34-38 hours post r-hCG day {end of stimulation cycle} [approximately 28 days]) | — |
| Mean Number of Follicles Greater Than or Equal to 14 Millimeter (mm) on Recombinant Human Choriogonadotropin (r-hCG) Day | r-hCG day (end of stimulation cycle [approximately 28 days]) | — |
| Number of Ovarian Stimulation Days | S1 up to r-hCG day (end of stimulation cycle [approximately 28 days]) | Ovarian stimulation included from first rFSH injection (S1) until day on which r-hCG was administered (r-hCG day). This period was divided into 2 parts: the first period in which 300 International Unit (IU) rFSH dose was constant and which covered from S1 to Day 4 of stimulation period (S4); the second period in which the rFSH dose could be adjusted depending on the ovarian response and which began on S4 and finished on the day on which the criteria for administration of r-hCG to induce the final follicular maturation were met. |
| Number of Recombinant Human Choriogonadotropin (r-hCG) Cycles Cancelled Due to Poor Response | Up to 2 months after OPU (34-38 hours post r-hCG day {end of stimulation cycle} [approximately 28 days]) | Poor response was defined as 3 or less follicles of greater than or equal to 12 mm developing following at least 7 days of study treatment. |
| Total Number of Births | Up to 2 months after OPU (34-38 hours post r-hCG day {end of stimulation cycle} [approximately 28 days]) | Total number of births per reporting group was calculated. |
| Number of Participants With Adverse Events (AEs) | Baseline up to 2 months after OPU (34-38 hours post r-hCG day {end of stimulation cycle} [approximately 28 days]) | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. |
| Number of Participants With Ovarian Hyper Stimulation Syndrome (OHSS) | Baseline up to 2 months after OPU (34-38 hours post r-hCG day {end of stimulation cycle} [approximately 28 days]) | OHSS is a syndrome which can manifest with enlarged ovaries, advanced ascites with increased vascular permeability, pleural fluid accumulation, hemoconcentration, and increased blood clotting. |
| Number of Cycles Cancelled Due to Risk of Ovarian Hyper Stimulation Syndrome (OHSS) | Baseline up to 2 months after OPU (34-38 hours post r-hCG day {end of stimulation cycle} [approximately 28 days]) | OHSS is a syndrome which can manifest with enlarged ovaries, advanced ascites with increased vascular permeability, pleural fluid accumulation, hemoconcentration, and increased blood clotting. |
| Estradiol (E2) Levels on r-hCG Day | r-hCG day (end of stimulation cycle [approximately 28 days]) | — |
Countries
Spain
Participant flow
Pre-assignment details
One out of 76 randomized participants did not receive study medication.
Participants by arm
| Arm | Count |
|---|---|
| rFSH + rhLH Recombinant human luteinizing hormone (rhLH, Luveris®) injection 150 International Units (IU) subcutaneously daily along with recombinant follicle-stimulating hormone (rFSH) 300 IU subcutaneously daily from Day 1 of stimulation period (S1) to Day 4 of stimulation period (S4) and then rFSH dose adjusted depending on the ovarian response till recombinant human choriogonadotropin (r-hCG) administration day. | 40 |
| rFSH Recombinant follicle stimulating hormone (rFSH) injection 300 IU subcutaneously daily from S1 to S4 and then dose adjusted depending on the ovarian response till r-hCG administration day. | 35 |
| Total | 75 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal before r-hCG administration | 6 | 1 |
| Overall Study | Withdrawal between OPU - embryo transfer | 3 | 2 |
| Overall Study | Withdrawal between rhCG-ovum pickup(OPU) | 1 | 1 |
Baseline characteristics
| Characteristic | rFSH + rhLH | rFSH | Total |
|---|---|---|---|
| Age, Continuous | 37.2 years STANDARD_DEVIATION 2.2 | 37.3 years STANDARD_DEVIATION 1.5 | 37.2 years STANDARD_DEVIATION 1.9 |
| Sex: Female, Male Female | 40 Participants | 35 Participants | 75 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 17 / 40 | 8 / 35 |
| serious Total, serious adverse events | 2 / 40 | 1 / 35 |
Outcome results
Primary
Implantation Rate
Implantation rate was measured as the number of gestational sacs observed, divided by the number of embryos transferred.
Time frame: Day 35-42 post ovum pick-up (OPU) (34-38 hours post recombinant human choriogonadotropin day {end of stimulation cycle}[approximately 28 days])
Population: Intention to treat (ITT) population included all randomized participants who had received at least 1 dose of the study medication.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| rFSH + rhLH | Implantation Rate | 0.2 sacs per embryo | Standard Deviation 0.4 |
| rFSH | Implantation Rate | 0.2 sacs per embryo | Standard Deviation 0.3 |
p-value: 0.876295% CI: [-0.1546, 0.1568]Wilcoxon two sample test
Secondary
Estradiol (E2) Levels on r-hCG Day
Time frame: r-hCG day (end of stimulation cycle [approximately 28 days])
Population: ITT population included all randomized participants who had received at least 1 dose of the study medication. Here N represents the number of participants with plasma E2 levels at r-hCG day.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| rFSH + rhLH | Estradiol (E2) Levels on r-hCG Day | 1890.2 picogram/milliter (pg/mL) | Standard Deviation 1084.4 |
| rFSH | Estradiol (E2) Levels on r-hCG Day | 1621 picogram/milliter (pg/mL) | Standard Deviation 827.8 |
p-value: 0.4164Wilcoxon two sample test
Secondary
Mean Number of Follicles Greater Than or Equal to 14 Millimeter (mm) on Recombinant Human Choriogonadotropin (r-hCG) Day
Time frame: r-hCG day (end of stimulation cycle [approximately 28 days])
Population: ITT population included all randomized participants who had received at least 1 dose of the study medication.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| rFSH + rhLH | Mean Number of Follicles Greater Than or Equal to 14 Millimeter (mm) on Recombinant Human Choriogonadotropin (r-hCG) Day | 7.7 follicles | Standard Deviation 4.9 |
| rFSH | Mean Number of Follicles Greater Than or Equal to 14 Millimeter (mm) on Recombinant Human Choriogonadotropin (r-hCG) Day | 8.7 follicles | Standard Deviation 4 |
p-value: 0.3589ANOVA
Secondary
Mean Number of Oocytes Retrieved
Mean number of oocytes retrieved per reporting group on the day of OPU (34-38 hours post r-hCG day (end of stimulation cycle \[approximately 28 days\]) was calculated. Oocyte retrieval is a technique used in in-vitro fertilization in order to remove oocytes from the ovary of the female, enabling fertilization outside the body.
Time frame: 34-38 hours post r-hCG day (end of stimulation cycle [approximately 28 days])
Population: ITT population included all randomized participants who had received at least 1 dose of the study medication.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| rFSH + rhLH | Mean Number of Oocytes Retrieved | 5.9 oocytes | Standard Deviation 3.9 |
| rFSH | Mean Number of Oocytes Retrieved | 7.7 oocytes | Standard Deviation 4 |
p-value: 0.0629Wilcoxon two sample test
Secondary
Number and Quality of Embryos
Embryos were graded according to Spanish Association for the Study of Reproductive Biology (ASEBIR) criteria into different categories: (A) optimal quality with maximum capacity for implantation, (B) good quality with a high capacity for implantation, (C) regular with low possibility of implantation and (D) poor quality with very little possibility of implantation.
Time frame: Day 2-3 post OPU (34-38 hours post r-hCG day {end of stimulation cycle}[approximately 28 days])
Population: ITT population included all randomized participants who had received at least 1 dose of the study medication. Here N represents the number of participants who had at least one fertilized oocyte.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| rFSH + rhLH | Number and Quality of Embryos | A + B (good quality) | 69 embyros |
| rFSH + rhLH | Number and Quality of Embryos | C + D (poor quality) | 56 embyros |
| rFSH + rhLH | Number and Quality of Embryos | Total embryos | 125 embyros |
| rFSH | Number and Quality of Embryos | A + B (good quality) | 65 embyros |
| rFSH | Number and Quality of Embryos | C + D (poor quality) | 73 embyros |
| rFSH | Number and Quality of Embryos | Total embryos | 138 embyros |
Secondary
Number of Cycles Cancelled Due to Risk of Ovarian Hyper Stimulation Syndrome (OHSS)
OHSS is a syndrome which can manifest with enlarged ovaries, advanced ascites with increased vascular permeability, pleural fluid accumulation, hemoconcentration, and increased blood clotting.
Time frame: Baseline up to 2 months after OPU (34-38 hours post r-hCG day {end of stimulation cycle} [approximately 28 days])
Population: Safety population included all participants who had received at least 1 dose of the study medication.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| rFSH + rhLH | Number of Cycles Cancelled Due to Risk of Ovarian Hyper Stimulation Syndrome (OHSS) | 1 cycles |
| rFSH | Number of Cycles Cancelled Due to Risk of Ovarian Hyper Stimulation Syndrome (OHSS) | 0 cycles |
Secondary
Number of Fertilized Oocytes (2 Pronuclei [PN])
Oocytes were fertilized using Intra-cytoplasmic Sperm Injection (ICSI) technique which is an in-vitro fertilization procedure in which a single sperm is injected directly into an egg under a microscope. The appearance of two 2PN is the first sign of successful fertilization as observed during in vitro fertilization, and is usually observed after ICSI. The zygote is then termed 2PN.
Time frame: 34-38 hours post r-hCG day (end of stimulation cycle [approximately 28 days])
Population: ITT population included all randomized participants who had received at least 1 dose of the study medication.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| rFSH + rhLH | Number of Fertilized Oocytes (2 Pronuclei [PN]) | 128 2PN oocytes |
| rFSH | Number of Fertilized Oocytes (2 Pronuclei [PN]) | 136 2PN oocytes |
p-value: 0.095Fisher Exact
Secondary
Number of Mature Oocytes Retrieved
Number of mature oocytes retrieved per reporting group on the day of OPU (34-38 hours post r-hCG day (end of stimulation cycle \[approximately 28 days\]) was calculated. Oocyte retrieval is a technique used in in-vitro fertilization in order to remove oocytes from the ovary of the female, enabling fertilization outside the body. The nuclear maturity was evaluated based on the presence of a germinal vesicle (GV) or whether oocytes were in metaphase I (Meta-I) or II (Meta-II) stage.
Time frame: 34-38 hours post r-hCG day (end of stimulation cycle [approximately 28 days])
Population: ITT population included all randomized participants who had received at least 1 dose of the study medication.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| rFSH + rhLH | Number of Mature Oocytes Retrieved | 234 mature oocytes |
| rFSH | Number of Mature Oocytes Retrieved | 271 mature oocytes |
p-value: 0.4728ANOVA
Secondary
Number of Ovarian Stimulation Days
Ovarian stimulation included from first rFSH injection (S1) until day on which r-hCG was administered (r-hCG day). This period was divided into 2 parts: the first period in which 300 International Unit (IU) rFSH dose was constant and which covered from S1 to Day 4 of stimulation period (S4); the second period in which the rFSH dose could be adjusted depending on the ovarian response and which began on S4 and finished on the day on which the criteria for administration of r-hCG to induce the final follicular maturation were met.
Time frame: S1 up to r-hCG day (end of stimulation cycle [approximately 28 days])
Population: ITT population included all randomized participants who had received at least 1 dose of the study medication.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| rFSH + rhLH | Number of Ovarian Stimulation Days | 9.7 Days | Standard Deviation 2.1 |
| rFSH | Number of Ovarian Stimulation Days | 9.8 Days | Standard Deviation 1.9 |
p-value: 0.5952Wilcoxon two sample test
Secondary
Number of Participants With Adverse Events (AEs)
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.
Time frame: Baseline up to 2 months after OPU (34-38 hours post r-hCG day {end of stimulation cycle} [approximately 28 days])
Population: Safety population included all participants who had received at least 1 dose of the study medication.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| rFSH + rhLH | Number of Participants With Adverse Events (AEs) | 19 participants |
| rFSH | Number of Participants With Adverse Events (AEs) | 9 participants |
Secondary
Number of Participants With Biochemical Pregnancies
Biochemical pregnancy was defined as a pregnancy diagnosed only by the detection of hCG in serum or urine and that does not develop into a clinical pregnancy.
Time frame: 2 months after OPU (34-38 hours post r-hCG day {end of stimulation cycle} [approximately 28 days])
Population: ITT population included all randomized participants who had received at least 1 dose of the study medication.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| rFSH + rhLH | Number of Participants With Biochemical Pregnancies | 11 participants |
| rFSH | Number of Participants With Biochemical Pregnancies | 10 participants |
p-value: 0.917995% CI: [0.4655, 1.99]Chi-squared
Secondary
Number of Participants With Clinical Pregnancies
Clinical pregnancy was defined as pregnancy diagnosed by ultrasonographic visualization of one or more gestational sacs or definitive clinical signs of pregnancy. It includes ectopic pregnancy.
Time frame: 2 months after OPU (34-38 hours post r-hCG day {end of stimulation cycle} [approximately 28 days])
Population: ITT population included all randomized participants who had received at least 1 dose of the study medication.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| rFSH + rhLH | Number of Participants With Clinical Pregnancies | 10 participants |
| rFSH | Number of Participants With Clinical Pregnancies | 10 participants |
p-value: 0.727195% CI: [0.4133, 1.8524]Chi-squared
Secondary
Number of Participants With Ovarian Hyper Stimulation Syndrome (OHSS)
OHSS is a syndrome which can manifest with enlarged ovaries, advanced ascites with increased vascular permeability, pleural fluid accumulation, hemoconcentration, and increased blood clotting.
Time frame: Baseline up to 2 months after OPU (34-38 hours post r-hCG day {end of stimulation cycle} [approximately 28 days])
Population: Safety population included all participants who had received at least 1 dose of the study medication.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| rFSH + rhLH | Number of Participants With Ovarian Hyper Stimulation Syndrome (OHSS) | 1 participants |
| rFSH | Number of Participants With Ovarian Hyper Stimulation Syndrome (OHSS) | 0 participants |
Secondary
Number of Recombinant Human Choriogonadotropin (r-hCG) Cycles Cancelled Due to Poor Response
Poor response was defined as 3 or less follicles of greater than or equal to 12 mm developing following at least 7 days of study treatment.
Time frame: Up to 2 months after OPU (34-38 hours post r-hCG day {end of stimulation cycle} [approximately 28 days])
Population: ITT population included all randomized participants who had received at least 1 dose of the study medication.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| rFSH + rhLH | Number of Recombinant Human Choriogonadotropin (r-hCG) Cycles Cancelled Due to Poor Response | 4 cycles |
| rFSH | Number of Recombinant Human Choriogonadotropin (r-hCG) Cycles Cancelled Due to Poor Response | 1 cycles |
Secondary
Total Dose of Recombinant Follicle Stimulating Hormone (r-FSH)
Time frame: 2 months after OPU (34-38 hours post r-hCG day {end of stimulation cycle} [approximately 28 days])
Population: ITT population included all randomized participants who had received at least 1 dose of the study medication.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| rFSH + rhLH | Total Dose of Recombinant Follicle Stimulating Hormone (r-FSH) | 2812.2 IU | Standard Deviation 719.4 |
| rFSH | Total Dose of Recombinant Follicle Stimulating Hormone (r-FSH) | 2970.3 IU | Standard Deviation 748.2 |
p-value: 0.3267Wilcoxon two sample test
Secondary
Total Number of Births
Total number of births per reporting group was calculated.
Time frame: Up to 2 months after OPU (34-38 hours post r-hCG day {end of stimulation cycle} [approximately 28 days])
Population: ITT population included all randomized participants who had received at least 1 dose of the study medication. Here N represents number of participants evaluated for this measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| rFSH + rhLH | Total Number of Births | 10 births |
| rFSH | Total Number of Births | 9 births |
p-value: 0.885295% CI: [0.4347, 2.0518]Chi-squared